510(k) Report

FDA applicant

Cardiac Pacemakers, Inc.

Mchenry, IL76 decisions1977–20101 recall

FDA records 76 decisions for Cardiac Pacemakers, Inc. (Mchenry, IL) from 1977 to 2010: 76 510(k) clearances. Most are in product codes DXY (Implantable Pacemaker Pulse-Generator) and FRN (Pump, Infusion). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cardiac Pacemakers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Cardiac Pacemakers, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiac Pacemakers, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • DXYImplantable Pacemaker Pulse-Generator37decisions
  • FRNPump, Infusion8decisions
  • KRGProgrammer, Pacemaker7decisions
  • DTDPacemaker Lead Adaptor5decisions
  • DWSInstruments, Surgical, Cardiovascular2decisions
  • DQYCatheter, Percutaneous2decisions

Also: DXH (2), DRB (2), DTA (1), FMF (1), DRR (1), FPA (1).

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K905674Lead StyletCardiac Pacemakers, Inc. · 19914cite it
  • K093969Acuity Break-Away Guide CatheterCardiac Pacemakers, Inc. · 20102cite it
  • K843060SentraCardiac Pacemakers, Inc. · 19841cites it

What has FDA decided for it lately?

  • K093969Acuity Break-Away Guide CatheterCardiac Pacemakers, Inc. · 2010
  • K080154Acuity Universal CutterCardiac Pacemakers, Inc. · 20081 recall
  • K934727Replacement Parts for Cpi 6888 Lead TunnelerCardiac Pacemakers, Inc. · 1994
  • K920601Astra T2, Astra T4, Astra T6Cardiac Pacemakers, Inc. · 1992
  • K912379PDT Carryall Transmitter, Various ModelsCardiac Pacemakers, Inc. · 1991
  • K905674Lead StyletCardiac Pacemakers, Inc. · 1991
  • K900498Modified Betatron IV Insulin Infusion SystemCardiac Pacemakers, Inc. · 1990
  • K894738Model 6888 Lead TunnelerCardiac Pacemakers, Inc. · 1989

All 76 as Cardiac Pacemakers, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K080154ACUITY Universal Cutter, MODEL 7060 - Product Usage: intended to facilitate guide…Dec 15, 2020Class II